Effect of a Low FODMAP Diet on SIBO

SIBO Clinical Trial

Official title:

Effect of a Low FODMAP Diet on SIBO

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04627727
• Other study ID #: 2020P000622
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: December 15, 2024

Study information

• Verified date: December 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bloating is the most common symptom associated with disorders of brain-gut interaction (i.e., functional bowel disorders) such as irritable bowel syndrome, a disorder characterized by abdominal pain and altered bowel habits which affects up to 11% of world population. A common cause of bloating is small intestinal bacterial overgrowth (SIBO), a condition defined by excessive and/or abnormal type of bacteria in the small bowel. The potential role of SIBO for irritable bowel syndrome (IBS) was initially proposed by Pimentel et al. Using lactulose breath tests (LBTs), 78% of patients with IBS were also diagnosed with SIBO. After antibiotic therapy, 48% of patients no longer met the Rome criteria for IBS. A recent systematic review and meta-analysis concluded that the prevalence of SIBO is increased in IBS. Despite the clinical efficacy of LFD in improving symptoms of IBS-D, its mechanism of action is not clear. Recently, Zhou et al have shown FODMAPs induce colonic tight junction dysfunction and visceral hypersensitivity in rat models, both of which are reversible when rats were fed an LFD. They further showed that this effect of FODMAPs is mediated by microbial dysbiosis and elevated fecal lipopolysaccharide level. However, studies evaluating the effect of LFD on colonic permeability of humans are lacking. Studies have shown significant differences in intra-individual luminal and mucosal microbiome of patients with functional gastrointestinal disorders as well as an increase in Prevotella abundance in IBS patients with SIBO as compared with IBS patients without SIBO. Thus, the exact effect of FODMAP on intestinal permeability and mucosal microbiome in humans is not clear and needs further evaluation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18-65 years at the time of screening
• Meet Rome IV criteria for functional bloating
• IBS-SSS score of at 176 (0-500)
• SIBO positive

Exclusion Criteria:

• individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
• individuals with peanut, soy, or seafood allergies or insulin-dependent diabetes
• known history of celiac disease, inflammatory bowel disease or microscopic colitis
• prior small bowel or colonic surgery or cholecystectomy
• pregnant patients
• antibiotics, excluding topical, in the past 3 months

Related Conditions & MeSH terms

• SIBO

Intervention

Other:
• low FODMAP diet
low FODMAP diet

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum LPS level	change in serum LPS concentration from baseline to final	3 weeks
Other	serum zonulin level	change in serum zonulin concentration from baseline to final	3 weeks
Primary	SIBO diagnosis	presence or absence of SIBO	three weeks
Secondary	Rome IV Functional Bloating diagnostic criteria	Rome IV Functional Bloating	3 weeks
Secondary	IBS-SSS	change in IBS-SSS from baseline to final	3 weeks